Cleared Traditional

K021378 - PORTABLE HDX INTRAORAL X-RAY

K021378 is an FDA 510(k) clearance for PORTABLE HDX INTRAORAL X-RAY, manufactured by Dentalez Group. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K021378 · Dentalez Group · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
37d
Days
Class 2
Risk

K021378 is an FDA 510(k) clearance for the PORTABLE HDX INTRAORAL X-RAY. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Dentalez Group (Lancaster, US). The FDA issued a Cleared decision on June 7, 2002 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dentalez Group devices

FDA 510(k) Submission Details - K021378

510(k) Number K021378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2002
Decision Date June 07, 2002
Days to Decision 37 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 107d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EHD Device Classification - Class 2, Special Controls

Product Code EHD Unit, X-ray, Extraoral With Timer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - EHD Unit, X-ray, Extraoral With Timer

All 105
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K021378.
ORTHOPHOS XG DS/CEPH
K033073 · Sirona Dental Systems GmbH · Oct 2003
A/T X-RAY 70
K024285 · Air Techniques, Inc. · Apr 2003
MODIFICATION TO FOCUS
K022630 · Instrumentarium Corp. · Oct 2002
VERAVIEWEPOCS, MODEL VE
K013955 · J. Morita USA, Inc. · Feb 2002
PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT
K011619 · Planmeca Oy · Jun 2001
FOCUS
K001729 · Instrumentarium Corp. · Jul 2000